Cleared Traditional

K895715 - HANAULUX 2000

K895715 is the FDA 510(k) clearance for HANAULUX 2000 by W.C. Heraeus GmbH. It is a Class 2 General & Plastic Surgery device (product code FTD) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K895715 · W.C. Heraeus GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
18d
Days
Class 2
Risk

K895715 is an FDA 510(k) clearance for the HANAULUX(R) 2000. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by W.C. Heraeus GmbH (West Germany, DE). The FDA issued a Cleared decision on October 13, 1989 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.C. Heraeus GmbH devices

Submission Details

510(k) Number K895715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date October 13, 1989
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTD Lamp, Surgical

All 10
Devices cleared under the same product code (FTD) and FDA review panel - the closest regulatory comparables to K895715.
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · Stryker Instruments · Jun 1998
STRYKER KNIFELIGHT
K961122 · Stryker Instruments · Aug 1996
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K931675 · Medline Industries, Inc. · Feb 1994
MINOR SURGICAL LIGHT MODEL 180
K841360 · American Sterilizer Co. · Apr 1984
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · Sybron Corp. · Jul 1981
PARKE-DAVIS SURGICAL LIGHT
K801353 · Warner-Lambert Co. · Jun 1980